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Adagrasib dose of twice daily

Phase 2

Advanced NSCLC | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 23, 2026

Target and mechanism

Molecular targetKRAS
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Adagrasib dose of twice daily · 1 trial · 2 indications

Phase 2 1
NCT05609578Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C MutationAdvanced NSCLC
ACTIVE NOT_RECRUITING90 Analytics
PHASE2ACTIVE NOT_RECRUITING
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Advanced NSCLCUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR) for Cohort A and E
30 months

Defined as the percent of patients documented to have a confirmed CR or PR

Progression-free Survival (PFS) at six months for Cohort C
30 months

PFS is defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.

Secondary Endpoints

Adverse Events
30 months
Duration of Response (DOR)
30 months
Overall Survival (OS)
30 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A: PD-L1 TPS≥ 1% (Closed)EXPERIMENTALAdagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
Cohort CEXPERIMENTALAdagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
Cohort EEXPERIMENTALAdagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)

Interventions

NameTypeDescription
Adagrasib oral dose of 400 mg twice daily tabletsDRUGoral dose of 400 mg twice daily tablets
PembrolizumabCOMBINATION_PRODUCTIV infusion once every 3 weeks
Chemotherapy: PemetrexedCOMBINATION_PRODUCTIV infusion once every 3 weeks
Cisplatin/CarboplatinCOMBINATION_PRODUCTIV infusion once every 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites94

Cohort A\* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%. * Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squam...

Countries:United StatesFranceGreeceHungaryItalyPolandSpain
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Recent Changes (Last 90 Days)

MEDIUMJun 23, 2026NCT05609578Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 23, 2026NCT05609578Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Adagrasib dose of twice daily

What is Adagrasib used for in advanced NSCLC?

Adagrasib is an investigational small molecule being studied for the treatment of advanced non-small cell lung cancer (NSCLC). It is administered orally at a dose of 400 mg twice daily. The drug is currently in Phase 2 clinical development for this indication.

What does Adagrasib target?

Adagrasib targets the KRAS G12C mutation, a specific genetic alteration found in some cancers. The ongoing clinical trial specifically enrolls patients with advanced NSCLC who have this KRAS G12C mutation, indicating the drug's mechanism is directed at this mutated form of the KRAS protein.

Who makes Adagrasib?

Adagrasib is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced NSCLC.

What phase is Adagrasib in?

Adagrasib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, and it is designed to evaluate combination therapies with adagrasib in advanced NSCLC.

What clinical trials is Adagrasib in?

Adagrasib is being studied in a Phase 2 clinical trial with the identifier NCT05609578. This trial, titled 'Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation,' is active but not recruiting. It enrolls approximately 90 participants across multiple countries, including the United States, France, Greece, Hungary, Italy, Poland, and Spain.

Is Adagrasib the same as Adagrasib oral dose of 400 mg twice daily tablets?

Yes, Adagrasib is the same as the drug referred to as 'Adagrasib oral dose of 400 mg twice daily tablets.' The drug is administered orally at a dose of 400 mg twice daily, and this formulation is being evaluated in clinical trials for advanced NSCLC.